Methods of treating irritable bowel syndrome and other disorders caused by small intestinal bacterial overgrowth

• US 7,452,857 B2
• Filed: 09/23/2005
• Issued: 11/18/2008
• Est. Priority Date: 08/11/1999
• Status: Expired due to Term

• Current Assignee: Cedars-Sinai Medical Center (Cedars Sinai Health System)
• Original Assignee: Cedars-Sinai Medical Center (Cedars Sinai Health System)
• Inventors: Lin, Henry C., Pimentel, Mark
• Primary Examiner(s): NAVARRO, ALBERT MARK
• Application Number:
  US11/234,516
• Publication Number:
  US 20060029550A1
• Time in Patent Office: 1,152 Days
• Field of Search: 514/2, 424/184.1
• US Class Current: 514/1.1
• CPC Class Codes: A61K 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 31/164 of a carboxylic acid with an aminoalcohol, e.g. ceramides
• CPC Class Codes: A61K 31/19 Carboxylic acids, e.g. valproic acid salicylic acid A61K31/60
• CPC Class Codes: A61K 31/4164 1,3-Diazoles
• CPC Class Codes: A61K 31/43 Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula , e.g. penicillins, penems
• CPC Class Codes: A61K 31/437 the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
• CPC Class Codes: A61K 31/445 Non condensed piperidines, e.g. piperocaine
• CPC Class Codes: A61K 31/4468 having a nitrogen directly attached in position 4, e.g. clebopride, fentanyl
• CPC Class Codes: A61K 31/495 having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazinesA61K31/48 takes precedence ; with three nitrogen atoms A61K31/53
• CPC Class Codes: A61K 31/496 Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
• CPC Class Codes: A61K 31/5415 ortho- or peri-condensed with carbocyclic ring systems, e.g. phenothiazine, chlorpromazine, piroxicam
• CPC Class Codes: A61K 31/545 Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula: , e.g. cephalosporins, cefaclor, or cephalexine
• CPC Class Codes: A61K 31/575 substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
• CPC Class Codes: A61K 31/606 having amino groups
• CPC Class Codes: A61K 31/65 Tetracyclines
• CPC Class Codes: A61K 31/7036 having at least one amino group directly attached to the carbocyclic ring, e.g. streptomycin, gentamycin, amikacin, validamycin, fortimicins
• CPC Class Codes: A61K 31/7048 having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin , digitoxin or digoxin
• CPC Class Codes: A61K 31/7052 having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
• CPC Class Codes: A61K 38/02 Peptides of undefined number of amino acids; Derivatives thereof
• CPC Class Codes: A61K 38/14 Peptides containing saccharide radicals; Derivatives thereof , e.g. bleomycin, phleomycin, muramylpeptides or vancomycin
• CPC Class Codes: A61P 1/00 : Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 29/00 : Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 31/00 : Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 37/00 : Drugs for immunological or allergic disorders
• CPC Class Codes: C12Q 1/00 : Measuring or testing processes involving enzymes, nucleic acids or microorganisms measuring or testing apparatus with condition measuring or sensing means, e.g. colony counters, C12M1/34; Compositions therefor; Processes of preparing such compositions
• CPC Class Codes: G01N 2800/065 : Bowel diseases, e.g. Crohn, ulcerative colitis, IBS
• CPC Class Codes: G01N 33/56911 : Bacteria
• CPC Class Codes: H04L 67/125 : involving control of end-device applications over a network
• CPC Class Codes: H04L 69/08 : Protocols for interworking; Protocol conversion

Abstract

Disclosed is a method of diagnosing irritable bowel syndrome, fibromyalgia, chronic fatigue syndrome, depression, attention deficit/hyperactivity disorder, autoimmune diseases, such as multiple sclerosis and systemic lupus erythematosus, or Crohn'"'"'s disease, which involves detecting the presence of small intestinal bacterial overgrowth (SIBO) in a human subject having at least one symptom associated with a suspected diagnosis of any of those diagnostic categories. Also disclosed is a method of treating these disorders, and other disorders caused by SIBO, that involves at least partially eradicating a SIBO condition in the human subject. The method includes administration of anti-microbial or probiotic agents, or normalizing intestinal motility by employing a prokinetic agent. The method improves symptoms, including hyperalgesia related to SIBO and disorders caused by SIBO. Also disclosed is a kit for the diagnosis or treatment of irritable bowel syndrome, fibromyalgia, chronic fatigue syndrome, depression, attention deficit/hyperactivity disorder, autoimmune diseases, or Crohn'"'"'s disease.

Claims

1. A method of treating irritable bowel syndrome in a subject, comprising:

providing a composition comprising rifaximin; and

administering the composition to the subject in an amount sufficient to at least partially eradicate small intestinal bacterial overgrowth in the subject, whereby the irritable bowel syndrome is treated.

2. The method of claim 1, wherein treatment of irritable bowel syndrome comprises an improvement in a symptom associated with irritable bowel syndrome selected from the group consisting of diarrhea, bloating, constipation, abdominal pain, and combinations thereof.

3. The method of claim 1, wherein the rifaximin is administered orally.

4. The method of claim 1, wherein the composition comprises a unitized amount of rifaximin.

5. The method of claim 1, wherein the rifaximin is dehydrated rifaximin.

6. The method of claim 1, where in the rifaximin is lyophilized rifaximin.

7. The method of claim 1, wherein the administering results in an improvement of irritable bowel syndrome based on visual analog scores.

8. The method of claim 1, wherein the administering results in improvement of extraintestinal symptoms of irritable bowel syndrome.

9. The method of claim 8, wherein the extraintestinal symptoms include joint pain and fatigue.

10. The method of claim 1, wherein the administering results in complete eradication of the small intestinal bacterial overgrowth.

11. The method of claim 1, wherein the administering results in greater than 90% improvement in symptoms of irritable bowel syndrome.

12. A method of treating irritable bowel syndrome in a human subject, comprising:

providing a composition comprising rifaximin; and

administering the composition to the human subject, wherein the administering relieves symptoms of irritable bowel syndrome.

13. The method of claim 12, wherein the composition comprises a unitized amount of rifaximin.

14. The method of claim 12, wherein the rifaximin is dehydrated rifaximin.

15. The method of claim 12, where in the rifaximin is lyophilized rifaximin.

16. The method of claim 12, wherein the administering results in an improvement of irritable bowel syndrome based on visual analog scores.

17. The method of claim 12, wherein the administering results in improvement of extraintestinal symptoms of irritable bowel syndrome.

18. The method of claim 17, wherein the extraintestinal symptoms include joint pain and fatigue.

19. The method of claim 12, wherein the administering results in complete eradication of the small intestinal bacterial overgrowth.

20. The method of claim 12, wherein the administering results in greater than 90% improvement in symptoms of irritable bowel syndrome.

21. The method of claim 12, wherein the rifaximin is administered orally.